510(k) K252174

AquaCast Mask by Blessing Cathay Corporation — Product Code IYE

K252174 is an FDA 510(k) premarket notification submitted by Blessing Cathay Corporation for the device "AquaCast Mask". The FDA issued a decision of Substantially Equivalent on September 3, 2025. The device falls under product code IYE (Accelerator, Linear, Medical), a Class II device regulated under 21 CFR 892.5050.